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Uso de registros cardiovasculares en procesos regulatorios : perspectivas del Colaboratorio Cardiovascular EU-MDR

Spitzer, Ernest ; de la Torre Hernández, José M. ; Guðmundsdóttir, Ingibjörg Jóna ; McFadden, Eugene ; Held, Claes ; Hanet, Claude ; Boersma, Eric ; Ren, Claire B. ; Delgado, Victoria and Erlinge, David LU orcid , et al. (2024) In REC: Interventional Cardiology 6(3). p.213-223
Abstract

On May 26, 2021, the European Medical Device Regulation (EU-MDR) entered into effect resulting in a major shift in the requirements for assessment of medical devices in Europe. The EU-MDR Cardiovascular Collaboratory (EU-MCVC) was founded to contribute to the development of faster, more efficient, and more effective pathways for innovation of cardiac medical devices. A registry is an organized system that collects uniform data and evaluates specified outcomes in a population defined by a disease, condition, or exposure. Most registries have been created to improve the quality of care and provide feedback to physicians, hospitals, and health providers. Clinical registries represent an ideal construct for scientific, clinical, and... (More)

On May 26, 2021, the European Medical Device Regulation (EU-MDR) entered into effect resulting in a major shift in the requirements for assessment of medical devices in Europe. The EU-MDR Cardiovascular Collaboratory (EU-MCVC) was founded to contribute to the development of faster, more efficient, and more effective pathways for innovation of cardiac medical devices. A registry is an organized system that collects uniform data and evaluates specified outcomes in a population defined by a disease, condition, or exposure. Most registries have been created to improve the quality of care and provide feedback to physicians, hospitals, and health providers. Clinical registries represent an ideal construct for scientific, clinical, and policy-making collaboration. We describe diverse experiences from 5 European countries and address the traditional quality components in clinical trials. Continued collaboration is expected among academics, clinical trialists, patient representatives, regulatory experts, research organizations, registry platforms, regulatory bodies, and industry partners. Data quality is a primary concern and registry leaders need to optimize data quality to become regulatory compliant. A collaborative approach among medical device stakeholders may improve quality of care, reduce costs, and provide faster access to innovative technologies, with the common objective of improving cardiovascular care and outcomes.

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organization
alternative title
Use of cardiovascular registries in regulatory pathways : perspectives from the EU-MDR Cardiovascular Collaboratory
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Clinical registries, Clinical trials, Regulatory science
in
REC: Interventional Cardiology
volume
6
issue
3
pages
11 pages
publisher
Permanyer Publications
external identifiers
  • scopus:85203651073
ISSN
2604-7306
DOI
10.24875/RECIC.M24000445
language
Spanish
LU publication?
yes
id
fda909c7-9850-4bc2-ad7f-a5ee2547f953
date added to LUP
2024-11-26 11:06:12
date last changed
2024-11-26 11:07:32
@article{fda909c7-9850-4bc2-ad7f-a5ee2547f953,
  abstract     = {{<p>On May 26, 2021, the European Medical Device Regulation (EU-MDR) entered into effect resulting in a major shift in the requirements for assessment of medical devices in Europe. The EU-MDR Cardiovascular Collaboratory (EU-MCVC) was founded to contribute to the development of faster, more efficient, and more effective pathways for innovation of cardiac medical devices. A registry is an organized system that collects uniform data and evaluates specified outcomes in a population defined by a disease, condition, or exposure. Most registries have been created to improve the quality of care and provide feedback to physicians, hospitals, and health providers. Clinical registries represent an ideal construct for scientific, clinical, and policy-making collaboration. We describe diverse experiences from 5 European countries and address the traditional quality components in clinical trials. Continued collaboration is expected among academics, clinical trialists, patient representatives, regulatory experts, research organizations, registry platforms, regulatory bodies, and industry partners. Data quality is a primary concern and registry leaders need to optimize data quality to become regulatory compliant. A collaborative approach among medical device stakeholders may improve quality of care, reduce costs, and provide faster access to innovative technologies, with the common objective of improving cardiovascular care and outcomes.</p>}},
  author       = {{Spitzer, Ernest and de la Torre Hernández, José M. and Guðmundsdóttir, Ingibjörg Jóna and McFadden, Eugene and Held, Claes and Hanet, Claude and Boersma, Eric and Ren, Claire B. and Delgado, Victoria and Erlinge, David and de Prado, Armando Pérez and Bax, Jeroen J. and Tijssen, Jan G.P.}},
  issn         = {{2604-7306}},
  keywords     = {{Clinical registries; Clinical trials; Regulatory science}},
  language     = {{spa}},
  number       = {{3}},
  pages        = {{213--223}},
  publisher    = {{Permanyer Publications}},
  series       = {{REC: Interventional Cardiology}},
  title        = {{Uso de registros cardiovasculares en procesos regulatorios : perspectivas del Colaboratorio Cardiovascular EU-MDR}},
  url          = {{http://dx.doi.org/10.24875/RECIC.M24000445}},
  doi          = {{10.24875/RECIC.M24000445}},
  volume       = {{6}},
  year         = {{2024}},
}